It has often been asserted, but not proven, that women were routinely
excluded from research studies conducted by the National Institutes of
Health. As early as 1993, Marcia Angell, MD, associate editor of the New
England Journal of Medicine, alleged, "There is little doubt that women
have been systematically excluded as subjects for study . . . it is not
surprising that most clinical trials have been heavily, if not exclusively,
weighted toward men". (New England Journal of Medicine 1993
329: 271-272). At a public health conference on January 28, 2000, NIH
acting director Ruth Kirschstein informed a startled audience that the
Framingham Heart Study was "all-male."

The statements by Angell and others were based on the fact that
certain studies such as the Coronary Primary Prevention Trial, the
Multiple Risk Factor Intervention Trial (MRFIT), and the Physicians'
Health Study were all-male. But the NIH sponsors thousands of studies
every year, and one must question the logic of generalizing from the sex
composition of a handful of studies to the universe of all NIH research.

But to this point in time, the claim of the routine exclusion of women
could never be definitively refuted because no one had actually done a
count of sex-specific enrollments in medical research, especially prior
to 1990. Recently Curtis Meinert, PhD of Johns Hopkins University and
colleagues undertook an exhaustive review of all 342 clinical trials
published in 1985 and 1990 in five leading medical journals (Controlled
Clinical Trials 2000; 21: 462-475). They tallied the number of enrollees
in these trials: 126,234 males and 343,675 females. Hardly an example of
the routine exclusion of women.

In my research, I have undertaken Medline database searches of the
epidemiological literature. I used the search delimiters "Epidemiology,"
"United States," "Human," "1966-1990," and "Male" or "Female." These
are the results for the five leading causes of death in the United States:

Overall, it is seen that there were 334 more epidemiological studies
that included men than included women, representing a 3.7% difference.
I have analyzed a broader range of conditions, and found very similar
findings. Again, it is hard to find evidence that women were
shortchanged by epidemiological research.

As far as the claim that the Framingham Heart Study was "all-male,"
women represented 51% of the research cohort at the inception of the
study in 1948. Due to sex-specific differentials in mortality rates, the
percentage of women eventually rose to 60%. (Journal of the American
Medical Women's Association 1993; Vol. 48, No. 5).

Unfortunately, the widespread perception that women were neglected
by medical research has overshadowed the reality. As a result, laws have
been passed, regulations have been promulgated, and new reporting
requirements instituted. More significantly, women's health research has
enjoyed a rapid expansion.

Now, attention to men's health research has begun to lag significantly.
According to the NIH, male participation in all extramural research studies
in 1994 was 44.9%. By 1998, that percentage had dropped to just 32.2%.
According to the recent GAO report on Women's Health, NIH now devotes
15.5% of its budget to women's health, vs. 6.4% on men's health.

For the sake of good science and for the sake of fairness, it would
seem that we need to reconsider the belief that women were routinely
excluded or generally underrepresented in medical research studies
sponsored by the NIH.